Research Pipeline

(NCE)

Mechanism:TRPA1 Inhibitor

Primary Indication:Neuropathic Pain

Overview

GRC 17536, a TRPA1 antagonist, has been proven highly efficacious in treating inflammatory and neuropathic pain in animal models. GRC 17536 has shown positive data in a Phase 2a proof of concept study in patients with painful diabetic neuropathy conducted in Europe and India. Phase 2 enabling toxicology studies have been completed and GRC 17536 has shown a good safety profile supporting further development. Glenmark has submitted an IND for a Phase 2b dose range finding study with the US FDA. The Agency has requested additional information with some additional changes to the clinical protocol. Glenmark is working to address the questions and ensure minimal delay in the start-up of the study.

GRC 27864

Relief from Osteoarthritic pain

mPGES-1 Inhibitor

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New Chemical Entity

(NCE)

Mechanism:mPGES-1 Inhibitor

Primary Indication:Relief from Osteoarthritic pain

Overview

Glenmark’s Novel Chemical Entity (NCE) 'GRC 27864' is a potent, selective, and orally bioavailable inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1), a novel therapeutic target in pain management, which is up-regulated under inflammatory conditions. Selectively blocking the mPGES-1 enzyme is a novel strategy and expected to selectively inhibit increased prostaglandin E2 (PGE2) production during the disease state, without affecting other prostanoids of physiological importance and, consequently, may be devoid of the gastrointestinal and cardiovascular side effects seen with NSAIDs and COX-2 inhibitors, respectively.

Glenmark has successfully completed preclinical studies and Phase I enabling toxicity studies for GRC 27864. A Phase I first-in-human single ascending dose and a multiple ascending dose study has been completed in the UK with no safety concerns. A relative bioavailability study with a tablet formulation is currently on going in France.

Vatelizumab (GBR 500)

Multiple Sclerosis

VLA – 2 Antagonist (mAb)

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Novel Biological Entity

(NBE)

Mechanism:VLA – 2 Antagonist (mAb)

Primary Indication:Multiple Sclerosis

Overview

GBR 500, a monoclonal antibody, is an antagonist of the VLA-2 (alpha2-beta1) integrin. GBR 500 has been licensed to Sanofi for testing in a Multiple Sclerosis (MS) Phase II clinical study.

Sanofi has made the decision not to pursue further Vatelizumab as a potential Relapsing-Remitting MS therapy, following the results of a pre-planned interim analysis that revealed the primary efficacy endpoint was not met. This decision is not due to safety concerns. Glenmark will continue to pursue the relicensing of GBR 500 after it is returned from Sanofi.

GBR 830

Autoimmune disease

OX40 Antagonist (mAb)

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Novel Biological Entity

(NBE)

Mechanism:OX40 Antagonist (mAb)

Primary Indication:Autoimmune disease

Overview

GBR 830, the first anti-OX40 monoclonal antibody, was discovered at the Glenmark Biologics Research Centre located in Switzerland. The development of OX40 antagonists has been very challenging and Glenmark has achieved a significant milestone with the successful generation of an antagonistic OX40 monoclonal antibody coupled with generation of data validating the role of OX40 in autoimmune diseases. GBR 830 shows great promise to emerge as a valuable therapeutic option to treat patients suffering from autoimmune diseases.

GBR 830 completed the clinical Phase 1 dosing successfully in The Netherlands. GBR 830 was well tolerated and its safety & pharmacokinetics profile in healthy volunteers fully support the transition into clinical Phase 2 studies. Glenmark has an open IND at the U.S. FDA and Health Canada approval to initiate dosing for Phase 2 study in atopic dermatitis.

GBR 900

Inflammatory pain

TrkA Antagonist

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Novel Biological Entity

(NBE)

Mechanism:TrkA Antagonist

Primary Indication:Inflammatory pain

Overview

Glenmark licensed the exclusive intellectual property rights for monoclonal antibodies against the neuronal growth factor receptor TrkA from Lay Line Genomics, Italy. TrkA is part of the NGF-TrkA axis, a validated and novel pain receptor system for treatment of chronic pain. Phase I enabling toxicity studies for GBR 900 have been completed successfully. A Phase I clinical trial has been initiated in the UK. GBR 900 is the first anti-TrkA monoclonal antibody to enter clinical development.

(NBE)

Mechanism:HER2xCD3 (bispecific mAb)

Overview

GBR 1302, a HER2xCD3 bispecific antibody, is the first clinical candidate based on Glenmark’s proprietary best in class BEAT® platform and also GBR 1302 is Glenmark’s first clinical candidate targeting oncology indications. The BEAT® antibody technology platform facilitates the efficient development and manufacturing of antibodies with dual specificities called bispecific antibodies. .

GBR 1302, a HER2xCD3 bi-specific antibody has successfully completed the preclinical evaluation phase. In pre-clinics, GBR 1302 has demonstrated superiority over current antibody therapies against most HER2 positive cancers, including breast cancer. Glenmark has submitted an application to conduct Phase 1 clinical trials for GBR 1302 with the Paul Ehrlich Institute (PEI), Germany, and expects to initiate dosing in this financial year. If confirmed in clinical trials, GBR 1302 could constitute an innovative treatment for HER2 positive cancers, potentially superior to the currently available monoclonal antibody treatments.

GBR 1342

Multiple myeloma

CD38xCD3 (bispecific mAb)

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Novel Biological Entity

(NBE)

Mechanism:CD38xCD3 (bispecific mAb)

Primary Indication:Multiple myeloma

Overview

GBR 1342 is a CD38xCD3 bi-specific antibody based on Glenmark’s proprietary BEAT® platform. GBR 1342 is the second clinical development candidate based on the BEAT® technology. It is also Glenmark’s second clinical candidate targeting oncology indications. GBR 1342 targets CD38, a target for multiple myeloma and potentially other malignancies of hematopoietic origin. Glenmark has initiated IND-enabling studies for GBR 1342 and is committed to moving GBR 1342 rapidly into clinical trials.

Non-core assets include GRC 17536, GBR 900 and GBR 500. These 3 molecules and GRC 27864 are candidates for out-licensing.

BEAT® Platform

Glenmark's proprietary platform for bispecific antibodies at the cutting edge of science